Acute Myeloid Leukemia Clinical Trial
A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias
Summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).
Eligibility Criteria
Inclusion Criteria:
Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
Performance status greater than or equal to (>=) 50 by lansky scale (for participants less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for participants >=16 years of age)
Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula
Exclusion Criteria:
Received an allogeneic hematopoietic transplant within 60 days of screening
Active acute graft-versus-host disease of any grade or chronic graft-versus-host which is not well-controlled
Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment
Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia
Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any other known bone marrow failure syndrome
Prior exposure to menin-KMT2A inhibitors
Prior cancer immunotherapy (ie [that is], Chimeric Antigen Receptor-T Cell Therapy [CAR-T], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
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There are 10 Locations for this study
Birmingham Alabama, 35233, United States
Boston Massachusetts, 02115, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27514, United States
Charlotte North Carolina, 28203, United States
Cincinnati Ohio, 45229, United States
Memphis Tennessee, 38105, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Milwaukee Wisconsin, 53226, United States
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